The anti-TNFR2 antibody BI-1808 is part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy.
BI-1808 could represent a new class of immunomodulatory agent with the potential to improve efficacy of cancer therapy
STATUS
Efficacy in clinical Phase 1/2a study (NCT04752826) in CTCL
In June 2026, BioInvent announced updated clinical data from its ongoing Phase 2a trial evaluating BI-1808 in patients with advanced cutaneous T-cell lymphoma, CTCL. The data was presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden in a poster titled “Targeting TNFR2 with BI-1808 with or without pembrolizumab: Immune activation and promising responses in advanced cutaneous T-cell lymphomas (CTCLs)”. The poster highlights emerging translational, efficacy and safety findings from the Phase 2a cohort in patients with advanced CTCL, including mycosis fungoides and Sézary syndrome. Data in summary:
- BI-1808 monotherapy achieves 40% objective response rate (ORR), including a complete response ongoing at two years, and a 93 % disease control rate (DCR)
- 50% ORR and 75% DCR in combination with KEYTRUDA® (pembrolizumab)
- BI-1808’s Treg-depleting mechanism drives measurable immune activation in patients, confirmed by induction of IL-12, CXCL11 and CCL19 and increased CD8+ T-cell infiltration
- Selectively targeting TNFR2 to deplete Tregs and reactivate anti-tumor immunity, BI-1808 holds FDA Fast Track and Orphan Drug designations in CTCL.
Patients with advanced CTCL often experience limited and short-lived responses to available therapies. In this heavily pretreated population, BI-1808 demonstrated meaningful and durable clinical activity alongside clear biologic evidence of immune activation, including increased CD8-positive T-cell infiltration. These results highlight the therapeutic potential of targeting TNFR2 in CTCL.
STUDY DESIGN
The aim of Phase 2a (NCT04752826) is to further assess the safety and tolerability of BI-1808 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its pharmacokinetics and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS), the modified Severity-Weighted Assessment Tool (mSWAT) for CTCL.
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Since August 2021, BioInvent has had a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BI-1808 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
Read more about the ongoing Phase 1/2a study KEYNOTE-D20
Evaluation of BI-1808 for the treatment of solid tumors and T-cell lymphomas.